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Macroduct Advanced
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Model 3710Model Macroduct Advanced Sweat Collection System
Identity
- Trade Name
- Macroduct Advanced EUDAMEDMacroduct® Advanced 3710 Sweat Collection System FDA UDI
- Generic Name
- Sweat-induction iontophoresis system FDA UDI
- Device Name
- The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. FDA UDI
- Model / Reference
- Macroduct Advanced Sweat Collection System EUDAMEDModel 3710 EUDAMEDFDA UDI
- Description
- The Macroduct System is intended for clinical laboratory use by qualified personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis. FDA UDI
Identifiers
- Catalog Number
- Model 3710 FDA UDI
- Primary DI / UDI-DI
- 03661540304347 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540MacroAdvInducerS5 EUDAMED
- Direct Marketing DI
- 03661540304347 EUDAMED
- 510(k) Number
- K180627 FDA UDI
- FDA Product Code
- KTB FDA UDI
- EMDN Code
- Z12080408 SWEAT TEST STIMULATORS EUDAMED
- GMDN Term
- Sweat-induction iontophoresis system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5525 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Macroduct Advanced by Elitechgroup Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180627 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3661540MacroAdvInducerS5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED d8ed871a-ec55-4617-9cf7-1e563d56aa74 61 fields · synced Jul 24, 2026
- FDA UDI 181ff4c5-5bdc-4984-beca-168f8623e74f 36 fields · synced May 30, 2026
- FDA 510(k) K180627 1 fields · synced May 18, 2026